Research Highlights: Clinical Research

Significant Discrepancies in Clinical Trials: Mathieu and colleagues report in a JAMA study that the 2005 requirement that clinical trials be registered to publish in most medical journals has been flaunted by investigators. From the 323 reviewed trials, 89 were completely lacking registration, and 31% (46/147) of the properly registered trials showed discrepancies between registered and published outcomes. More so those trials with discrepancies favored statistically significant results. [1]

European Drug makers Ahead of US: Donald Light reexamines 1982 - 2003 chemical research data to find that European drug makers never fell behind US companies in production and innovation. Indeed many of the American innovations like Nexium and Lipitor, cited as models of innovative discoveries, are either imitators (Nexium) or have not been proven to be any more effective than other drugs (Lipitor). Light argues that pharmaceutical companies have produced imitators and incrementally useful (if at all) drugs, instead of funding research into superior clinical treatments. [2]

Vertebroplasty, Just Not that Useful: Kallmes and colleagues show that a common procedure used to seal vertebral fractures with cement is no more effective in relieving pain than a placebo incision and injection with a rapidly acting analgesic. The treatment, known as vertebroplasty, costs between $2,500 - $3,000 dollars and requires an additional $1,000 - $2,000 MRI scan. Currently regional discrepancies in use of the procedure exist, as noted by the accompanying editorial to the study, which can be here. The question is whether this work will lead doctors to change their behavior with regards to the procedure? [3]

Dangers of Medical Imaging - Radiation: In a new NEJM study, Fazel and colleagues used claims data from UnitedHealthcare to perfrom a cohort study on accumulated radiation doses from medical imaging devices that patients received. They found the mean effective dose to be 2.4±6.0 mSv/person/year, and the median effective dose to be 0.1 mSv/person/year. Out of the 952,420 subjects in the study, 655,613 (68.8%) were exposed to some form of radiation through scans over a three year period, with women undergoing more procedures than men. Questions about the accumulated doses from radiation are raised in the paper and the  accompanying editorial. [4]

Quick Highlight

Two New Studies Show 3 Genetic Variants are Linked to Alzheimers Disease. (Harold et al. and Lambert et al.) See the NY Times article for more information. 

References
1. Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials. JAMA. 2009. 302(9): 977-984.
2. Global Drug Discovery: Europe Is Ahead. Health Affairs. Web Exclusive: August, 25, 2009. doi: 10.1377/hlthaff.28.5.w969
3. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. NEJM. Volume 361:569-579.
4. Exposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures. NEJM. Volume 361:849-857.

Michael Shusterman is the Editor in Chief of TuftScope (2009 - 2010).